The U.S. Environmental Protection Agency (EPA) recently published a list of ethylene oxide (EO) sterilization plants around the country that may be linked to increased cases of cancer in nearby communities. With half of all U.S. medical devices sterilized with EO, the news is sounding alarm bells for developers.

Making the sterilization process safer is critically important. But there is more than one way to reduce emissions. Looking at the issue from product side, consider that if you can sterilize more product in each sterilization cycle, you’ll be able to substantially reduce EO emissions. In other words, design and use a chamber that can sterilize twice as much product, and you’ll reduce EO emissions by half.

Med device manufacturers looking to reduce EO emissions can follow these four tips.

1. Incorporate packaging design early in the development process. Medical device packaging is usually the last part of the design process to occur, resulting in less-effective outcomes. As a result, most devices are over-packaged. By designing your product with the end in mind, you’ll be able to develop the most efficient packaging. You’ll fit more product into the sterilization chambers – and reduce waste at the same time.
2. Design packaging to fit efficiently in the sterilization chamber. Work with your sterilization provider to understand the dimensions of their chambers. Use that information to design your packaging to maximize the amount of product you can sterilize per cycle.
3. Fill chambers. Make sure to always fill the sterilization chamber. Frequently, large chambers – such as those for one or two pallets – do not fill, because the manufacturer doesn’t have enough product. Sterilizing in a chamber that’s only half full will produce twice as much EO emission as needed for the actual product amount. Understand that for many med device developers, working with a provider that has smaller chambers may be the way to go.
4. Sterilize in the primary packaging. Typically, medical device packaging consists of primary packaging (a pouch), a shelf box (secondary packaging) and, finally, a shipping box. If you sterilize in the primary packaging, you’ll reap multiple EO emission-reduction benefits. First, more product will fit in the sterilization chamber. Second, you’ll significantly reduce the amount of cardboard in the chamber – material that soaks up the EO and then later releases it back into the chamber. Reduce the cardboard and reduce the emissions.

Here at Boulder iQ, our Boulder Sterilization division works with developers to sterilize product in the fastest, most cost-effective ways possible. Our process can reduce sterilization time by up to 80% and reduce cost by up to 75%. We work with smaller chambers and smart processes, and provide both clean room packaging and in-house biological testing – saving customers an average of 7 months and tens of thousands of dollars on sterilization validations.

The industry is focused on reducing EO emissions, which is the right thing to do. Looking at the issue from a different perspective can yield immediate, and important, results.

Peggy Fasano, former Chief Operating Officer, Boulder iQ